NCT02642185

Brief Summary

This study aims to prove that a strategy of first line local ablation of colorectal liver metastases with microwaves is not inferior to liver resections in terms of survival rates at three years with secondary endpoints being survival at five and ten years, interventional complication rates, length of stay, ablation precision measurements, need for further interventions and health-economic analysis. A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases \<31mm in size will be followed and compared with propensity scored matched controls from the Swedish liver surgery registry - Sweliv. The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6.1 years

First QC Date

October 30, 2015

Last Update Submit

March 30, 2022

Conditions

Neoplasm Metastasis

Keywords

microwaveablationresectionlivercolorectalsurvivalmetastasis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (9)

  • Overall survival

    5 years

  • Overall survival

    10 years

  • Complications to treatment

    1 year

  • Disease free survival

    3 years

  • Overall cost of treatment as measured in euros

    3 years

  • +4 more secondary outcomes

Study Arms (2)

Ablation

Patients that are primarily treated with microwave ablation of colorectal liver metastases

Procedure: Microwave ablation

Resection

Patients identified in the Swedish liver registry during the same time frame subjected to liver resection, propensity score matched to the ablation group

Procedure: Resection

Interventions

Microwave ablationPROCEDURE

CT-guided percutaneous ablation of 1-5, \<31mm in diameter, colorectal liver metastases, performed with any generic microwave ablation system cleared for clinical use

Ablation
ResectionPROCEDURE

Open or laparoscopic resection of liver metastases using standard of care surgical procedures

Resection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

European multicentre prospective cohort study with propensity score matching for number or tumours, age, gender and response to chemotherapy (no chemo - response/stable disease - progression). Patients with colorectal liver metastases are evaluated at a weekly liver multidisciplinary conference and a treatment strategy is decided. In this decision process patients that are resectable and have tumours of 30mm or less and not more than 5 in number, and deemed as both ablatable and resectable, will be offered treatment with an ablative strategy using state of the art targeting and microwave ablation devices.

You may qualify if:

  • Patients with 1-5 colorectal liver metastases
  • No metastases larger than 30 mm in diameter
  • All lesions amenable to CT-guided percutaneous microwave ablation
  • Patient also resectable
  • Patients so evaluated at the multidisciplinary tumor board meeting

You may not qualify if:

  • Kidney failure excluding the use of iv contrast medium
  • Lack of informed consent
  • Logistic reasons where patient does not live in the region of the treatment centre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Medical Centre

Groningen, Netherlands

Location

Karolinska Institutet, Dept of Surgery at Danderyd Hospital

Stockholm, 18288, Sweden

Location

Pascale Tinguely

Bern, Switzerland

Location

Related Publications (9)

  • www.livermetsurvey.com, annual statistics june 2014.

    BACKGROUND

  • Costi R, Leonardi F, Zanoni D, Violi V, Roncoroni L. Palliative care and end-stage colorectal cancer management: the surgeon meets the oncologist. World J Gastroenterol. 2014 Jun 28;20(24):7602-21. doi: 10.3748/wjg.v20.i24.7602.

    PMID: 24976699BACKGROUND

  • Pomfret EA, Pomposelli JJ, Gordon FD, Erbay N, Lyn Price L, Lewis WD, Jenkins RL. Liver regeneration and surgical outcome in donors of right-lobe liver grafts. Transplantation. 2003 Jul 15;76(1):5-10. doi: 10.1097/01.TP.0000079064.08263.8E.

    PMID: 12865779BACKGROUND

  • Dokmak S, Fteriche FS, Borscheid R, Cauchy F, Farges O, Belghiti J. 2012 Liver resections in the 21st century: we are far from zero mortality. HPB (Oxford). 2013 Nov;15(11):908-15. doi: 10.1111/hpb.12069. Epub 2013 Mar 6.

    PMID: 23461811BACKGROUND

  • Jones NB, McNally ME, Malhotra L, Abdel-Misih S, Martin EW, Bloomston M, Schmidt CR. Repeat hepatectomy for metastatic colorectal cancer is safe but marginally effective. Ann Surg Oncol. 2012 Jul;19(7):2224-9. doi: 10.1245/s10434-011-2179-0. Epub 2011 Dec 30.

    PMID: 22207046BACKGROUND

  • Nosher JL, Ahmed I, Patel AN, Gendel V, Murillo PG, Moss R, Jabbour SK. Non-operative therapies for colorectal liver metastases. J Gastrointest Oncol. 2015 Apr;6(2):224-40. doi: 10.3978/j.issn.2078-6891.2014.065.

    PMID: 25830041BACKGROUND

  • Pathak S, Jones R, Tang JM, Parmar C, Fenwick S, Malik H, Poston G. Ablative therapies for colorectal liver metastases: a systematic review. Colorectal Dis. 2011 Sep;13(9):e252-65. doi: 10.1111/j.1463-1318.2011.02695.x.

    PMID: 21689362BACKGROUND

  • Osaki Y, Nishikawa H. Treatment for hepatocellular carcinoma in Japan over the last three decades: Our experience and published work review. Hepatol Res. 2015 Jan;45(1):59-74. doi: 10.1111/hepr.12378. Epub 2014 Jul 18.

    PMID: 24965914BACKGROUND

  • Park EK, Kim HJ, Kim CY, Hur YH, Koh YS, Kim JC, Kim HJ, Kim JW, Cho CK. A comparison between surgical resection and radiofrequency ablation in the treatment of hepatocellular carcinoma. Ann Surg Treat Res. 2014 Aug;87(2):72-80. doi: 10.4174/astr.2014.87.2.72. Epub 2014 Jul 29.

    PMID: 25114886BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jacob Freedman, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

October 30, 2015

First Posted

December 30, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

SE(1)CH(1)NL(1)